Cleared Traditional

K942774 - POLYSKIN M.R. MOIST RESPONSIVE TRANSPAR...

K942774 · The Kendal Co. · General & Plastic Surgery device
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Jul 1994
Decision
37d
Days
-
Risk

K942774 is an FDA 510(k) clearance for the POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by The Kendal Co. (Franklin, US). The FDA issued a Cleared decision on July 20, 1994 after a review of 37 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Kendal Co. devices

FDA 510(k) Submission Details - K942774

510(k) Number K942774 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 13, 1994
Decision Date July 20, 1994
Days to Decision 37 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 115d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 13
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K942774.
CONMED VENI-GARD(TM I.V. DRESSING-PRODUCT LINE EXTENSION AND MODIFICATIONS
K950065 · Conmedcorp · Mar 1995
CUTIPLAST STERIL
K943363 · Beiersdorf, Inc. · Mar 1995
CUSH ISLAND DRESSING
K943424 · Cush Medical Products · Oct 1994
CUTIFILM(R) FILM
K926399 · Beiersdorf, Inc. · Nov 1993
DEROYAL TRANSPARENT FILM DRESSIGN
K920796 · Deroyal Industries, Inc. · Jul 1992
PROCEL BURN COVER
K915695 · W.L. Gore & Associates, Inc. · May 1992